Early Phase Study of KESONOTIDE™in Participants With Solid Tumours

Sponsor
Filamon LTD
Study ID
NCT06926075
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • A novel hGIIA-Vimentin Inhibitor — DRUG
    Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg.
  • Dose expansion — DRUG
    Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.

Study Details

This clinical trial is an adaptive study of a novel vimentin inhibitor in cancers. It is an open label, multicentre, single ascending dose level in phase I and cohort exploration in phase II. Primary objective is to evaluate safety and tolerability of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. Secondary objective is to characterise the pharmacokinetics of KESONOTIDE™. Phase I study will enrol 20-32 participants and Phase II approximately 80 participants.

Key Dates

First listed
Apr 13, 2025
Start date
Nov 7, 2025
Status verified
Mar 2026
Primary completion
Oct 26, 2027
Completion
Oct 26, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I, Single Arm, dose escalation
  • Experimental: 2 Arms of selected indication and recommended dose

Primary Outcome Measure

To evaluate the safety and tolerability (Incidence of SAEs) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. [ Time Frame: Cycle 1 (21 days) ]

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